Combined pulsed electromagnetic field and low intensity shockwave system and method

ABSTRACT

A method of treatment includes using an electrical energizing source coupled to a current conducting coil to cause the current conducting coil to produce pulsed electromagnetic fields. A conducting membrane is placed adjacent the current conducting coil and an insulating coupling interface is placed adjacent the membrane, such that the membrane is between the current conducting coil and the insulating coupling interface. One portion of the pulsed electromagnetic fields is intercepted by the membrane so that the membrane oscillates to generate acoustic waves to tissue adjacent the insulating coupling interface and another portion of the pulsed electromagnetic fields propagates through the insulating coupling interface to the tissue.

FIELD OF THE INVENTION

The present invention generally relates to a method and device forcombining pulsed electromagnetic field therapy with low intensityshockwave treatment, such as for treating the area of the pelvis,peritoneum or penis, e.g., for treatment of erectile dysfunction orother tissues and parts of the body.

BACKGROUND OF THE INVENTION

Pulsed electromagnetic fields may be used for nerve or brainstimulation, treating ailments like joint and muscle pain, and assistingwith the healing of broken bones and fractures.

A number of pulsed electromagnetic field therapy devices are availablewhich produce pulsed electromagnetic fields to provide a physiologicaleffect. They typically include a resonant circuit formed from acapacitor connected to a coil looped inductor through a switch (such asa semiconductor or spark gap switch). With the switch open, thecapacitor can be pre-charged before closing the switch to discharge thecapacitor into the inductor to initiate oscillation of the resonantcircuit. The resonant circuit then oscillates until the energy stored inthe resonant circuit is dissipated by the circuitry and the load. As theresonant circuit oscillates, it generates a sequence of electromagneticoscillations in the coil looped inductor which is placed adjacent to, oraround, a part of the body where the physiological effect of the pulsedelectromagnetic field is desired.

Low intensity shockwaves (LISW) applied to soft tissue are known toincrease blood flow in the tissue. LISW has been used to treat erectiledysfunction (ED), by increasing blood flow to the corpus cavernosum. Lowintensity shockwaves are pulsed acoustic waves whose wave front is notnecessarily steep as is characteristic of high intensity shockwaves.

SUMMARY OF THE INVENTION

The present invention seeks to provide a novel combination of pulsedelectromagnetic field (PEMF) therapy with low intensity shockwavetreatment (particularly electromagnetic low intensity shockwaves(ELIS)), such as for treating the area of the pelvis, peritoneum orpenis, e.g., for treatment of erectile dysfunction (ED) or Peyronie'sdisease (also known as induratio penis plastica), or other tissues andparts of the body, as is described more in detail hereinbelow. In thecase of ED, the invention can significantly improve penile hemodynamicsrequired for erection.

In the invention, both PEMF and ELIS (or simply LIS) use currentconducting coils to produce pulsed electromagnetic fields. The pulsedelectromagnetic field is applied directly to the target organ or tissuewhile the LIS field induces current in an adjacent conductive membrane,causing the membrane to jerk and produce acoustic waves.

In one embodiment, a combined PEMF/LIS transducer includes a currentconducting coil for producing a pulsed electromagnetic field, a thinconductive membrane, and a membrane-attached insulating couplinginterface, generally transparent to acoustic waves. Current pulsesdelivered to the conducting coil produce an electromagnetic field. Oneportion of the electromagnetic field is intercepted by the membrane,giving rise to acoustic waves (low intensity shockwaves) propagated viathe membrane-attached insulating coupling interface in the direction ofthe tissue (throughout, “tissue” encompasses either any tissue or anyorgan or both). Another portion of the electromagnetic field directlypropagates in the direction of the tissue as a pulsed electromagneticfield. The geometry and dimensions of the coil and membrane determinethe respective distributions of pulsed electromagnetic and acousticfields in the tissue.

In another embodiment, there are separate coils for PEMF and LIS, and atiming controller controls and triggers the respective current pulses.Accordingly, the coil and membrane geometry may be selected or adjustedand the respective trigger timing may be controlled for respectivelyproducing electromagnetic and acoustic fields at desired time intervals,e.g., for coinciding in time and space at desired tissue depth, due todifferent propagation speed of electromagnetic and acoustic waves.

There is provided in accordance with a non-limiting embodiment of theinvention a method of treatment including using an electrical energizingsource coupled to a current conducting coil to cause the currentconducting coil to produce pulsed electromagnetic fields, wherein amembrane is placed adjacent the current conducting coil and aninsulating coupling interface is placed adjacent the membrane, such thatthe membrane is between the current conducting coil and the insulatingcoupling interface, wherein one portion of the pulsed electromagneticfields is intercepted by the membrane so that the membrane oscillates togenerate acoustic waves to tissue adjacent the insulating couplinginterface and another portion of the pulsed electromagnetic fieldspropagates to the tissue.

The insulating coupling interface may be made of an acousticallytransparent material.

A controller may be coupled to the energizing source and/or to thecurrent conducting coil to control a shape, a duration, an intensity orother parameter of the pulsed electromagnetic fields.

The method may include using geometry and dimensions of the currentconducting coil and the membrane to determine respective distributionsof pulsed electromagnetic and acoustic fields in the tissue.

The method may include using separate current conducting coils togenerate pulsed electromagnetic fields and to generate acoustic waves.

The method may include using a controller to control operatingparameters of pulses of the coils for generating the pulsedelectromagnetic fields and the acoustic waves, and to control timingbetween pulses of the coils (e.g., at desired time intervals). Theseparate current conducting coils may be arranged in a pattern.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully fromthe following detailed description, taken in conjunction with thedrawings in which:

FIG. 1 is a simplified illustration of a combined pulsed electromagneticfield (PEMF) and low intensity shockwave (LIS) system, operative inaccordance with a non-limiting embodiment of the present invention;

FIG. 2 is a simplified illustration of a combined PEMF and LIS systemwith time control, operative in accordance with another non-limitingembodiment of the present invention; and

FIG. 3 is a simplified illustration of a combined PEMF and LIS systemwith time and spatial control, operative in accordance with anothernon-limiting embodiment of the present invention.

DETAILED DESCRIPTION

Reference is now made to FIG. 1, which illustrates a combined pulsedelectromagnetic field (PEMF) and low intensity shockwave (LIS) system,operative in accordance with an embodiment of the present invention.

The system may include a current conducting coil 10 to produce pulsedelectromagnetic fields. A thin (e.g., conductive) membrane 12 is placedadjacent (e.g., underneath) the current conducting coil 10. Amembrane-attached insulating coupling interface 14 is placed adjacent(e.g., underneath) membrane 12, such that membrane 12 is between currentconducting coil 10 and coupling interface 14.

The membrane-attached coupling interface 14 is made of an acousticallytransparent material, such as a matrix or substrate of an acousticallytransmissive material. In some embodiments, an acoustically transmissivematerial transmits at least about 70%, at least about 80%, at leastabout 90%, or at least about 95% of the acoustic wave energy from onesurface to the another surface. In some embodiments, an acousticallytransmissive material loses less than about 1 dB, less than about 2 dB,less than about 3 dB, less than about 4 dB, less than about 7 dB, orless than about 10 dB of sound energy from one side to the other side. Asuitable acoustically transparent material is the material commerciallyavailable as a LITTMAN CARDIOLOGY III diaphragm (from 3M, Minneapolis,Minn., USA), which is used for stethoscopes. Some woven cotton or linenfabrics are also acoustically transparent.

An electrical energizing source 16 is coupled to current conducting coil10 to produce the pulsed electromagnetic fields. A controller 18 may becoupled to electrical energy source 16 and/or coil 10 to control theshape, duration and other parameters of the pulsed electromagneticfields.

Current pulses delivered to conducting coil 10 produce anelectromagnetic field. One portion of the electromagnetic field isintercepted by membrane 12 so that induced current in membrane 12 causesmembrane 12 to move rapidly, which generates acoustic waves (lowintensity shockwaves) delivered via coupling interface 14 to a tissue 20(throughout, “tissue” encompasses either any tissue or any organ orboth). Another portion of the electromagnetic field propagates away frommembrane 12 directly or through the coupling interface 14 to the tissue20 as a pulsed electromagnetic field. The geometry and dimensions of thecoil and membrane determine the respective distributions of pulsedelectromagnetic and acoustic fields in the tissue.

Low intensity shockwaves and pulsed electromagnetic waves may usedifferent interfaces. LIS requires insulating, acoustically transparent,membrane attached, coupling interface; EM waves require insulating,EM-transparent, off-membrane interface of material like silicone,plastic or air. Using the same interface material for both LIS and EMwaves is possible but not necessary.

Reference is now made to FIG. 2. In this embodiment, there are separatecoils 10P and 10L for PEMF and LIS. The controller 18 is a timingcontroller that controls and triggers the respective current pulses.

Reference is now made to FIG. 3, which is similar to FIG. 2 in thatthere are separate PEMF and LIS coils, except that in FIG. 3 thesedifferent coils are arranged in a pattern, such as alternating segmentsin a matrix. Accordingly, in the embodiments of FIGS. 2 and 3, the coiland membrane geometry may be selected or adjusted and the respectivetrigger timing may be controlled for producing electromagnetic andacoustic fields at desired time intervals, e.g., for coinciding in timeand space.

What is claimed is:
 1. A method of treatment comprising: using anelectrical energizing source coupled to a current conducting coil tocause said current conducting coil to produce pulsed electromagneticfields, wherein a conducting membrane is placed adjacent said currentconducting coil and an insulating coupling interface is placed adjacentsaid membrane, such that said membrane is between said currentconducting coil and said insulating coupling interface; wherein oneportion of said pulsed electromagnetic fields is intercepted by saidmembrane so that induced current in said membrane causes the membrane tomove rapidly and generate acoustic waves to tissue adjacent saidinsulating coupling interface and another portion of said pulsedelectromagnetic fields propagates away from the membrane to said tissue.2. The method according to claim 1, wherein said insulating couplinginterface is made of an acoustically transparent material.
 3. The methodaccording to claim 1, comprising using a controller coupled to saidenergizing source and/or to said current conducting coil to control ashape, a duration, an intensity or other parameter of said pulsedelectromagnetic fields.
 4. The method according to claim 1, comprisingusing geometry and dimensions of said current conducting coil and saidmembrane to determine respective distributions of pulsed electromagneticand acoustic fields in said tissue.
 5. The method according to claim 1,comprising using separate current conducting coils to respectivelygenerate pulsed electromagnetic fields and to generate acoustic waves.6. The method according to claim 5, comprising using a controller tocontrol operating parameters of pulses of said coils for generating saidpulsed electromagnetic fields and said acoustic waves, and to controltiming between pulses of said coils.
 7. The method according to claim 5,wherein said separate current conducting coils are arranged in apattern.
 8. The method according to claim 1, comprising using acombination of said pulsed electromagnetic fields and said acousticwaves to treat organs or tissue in a pelvis, legs, a back or a shoulder.9. The method according to claim 1, comprising using a combination ofsaid pulsed electromagnetic fields and said acoustic waves to treaterectile dysfunction (ED) or pain in different body regions. 10.Apparatus for treatment comprising: an electrical energizing sourcecoupled to a current conducting coil to cause said current conductingcoil to produce pulsed electromagnetic fields, wherein a membrane isplaced adjacent said current conducting coil and an insulating couplinginterface is placed adjacent said membrane, such that said membrane isbetween said current conducting coil and said insulating couplinginterface; wherein one portion of said pulsed electromagnetic fieldsgenerated by said current conducting coil is intercepted by saidmembrane so that induced current in said membrane causes the membrane torapidly move and generate acoustic waves to tissue adjacent saidinsulating coupling interface and another portion of said pulsedelectromagnetic fields propagates away from the membrane to said tissue.